Vaporization system for delivery in a controlled concentration
Inventors
Assignees
Case Western Reserve University • University Hospitals Cleveland Medical Center
Publication Number
US-12296104-B2
Publication Date
2025-05-13
Expiration Date
2038-06-07
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Abstract
Devices for delivering a controlled concentration of an agent are provided. The device includes a reservoir for the agent and a flow control portion operably connected to the reservoir. The device also includes a valve for releasing the agent from the flow control portion and a pump for flowing air to mix with the agent released by the valve and for flowing the agent and air mixture out of the device. Methods of delivering a vaporized agent to a subject are also provided. The methods include storing a liquid agent in a reservoir of a device and flowing the agent into a flow control chamber to change the agent to a gas. The methods also include mixing the agent in gas form with air and flowing the agent and air mixture out of the device to be delivered to a subject.
Core Innovation
The invention provides devices and methods for delivering a controlled concentration of an agent, specifically designed for ambulatory use. The device includes a reservoir for storing a liquid agent, a flow control portion operably connected to the reservoir, a valve for releasing the agent after conversion to vapor, and a pump for mixing the vapor with air and delivering the mixture to the user. Key components, such as a temperature control unit, can precisely regulate the transformation and flow of the agent, achieving a specific, controlled output concentration.
The background highlights that conventional administration of ethyl nitrite (ENO) gas is cumbersome and not suitable for mobile patients, as it typically involves large, immobile gas tanks. Further, precise control over concentration is necessary to ensure a regulated ratio of ENO to hemoglobin in the subject. Therefore, the core problem addressed is the need for a portable, ambulatory system capable of delivering a nitrosylating agent like ENO in controlled concentrations, suitable for mobile patients.
The described methods entail storing the liquid agent in a reservoir, converting part of the agent to gas in a flow control chamber, and then mixing and delivering the agent-air mixture to the subject. The flow, transformation, and ultimately the delivered dose are managed via components such as temperature controllers, capillary tubing or gas expansion chambers, valves, pumps, sensors, and a user interface, allowing the system to deliver target concentrations, for example, ENO at about 0.1–100 ppm, reliably and safely outside of a traditional, stationary setting.
Claims Coverage
The patent includes two independent claims: one directed to an ambulatory device and one directed to a method of delivering a vaporized nitrosylating agent. There are several inventive features associated with these claims.
Ambulatory device with temperature-controlled vaporization and flow control
The ambulatory device comprises: - An exterior casing configured to be carried or worn by a user, enclosing the system components - A reservoir with a storage portion for a liquid phase of a nitrosylating agent and a dead space portion for a vapor phase - A flow control portion connected to the reservoir, configured to flow the vapor phase out from the reservoir - A temperature control unit configured to control a first temperature in the reservoir and a second temperature in the flow control portion, thereby controlling the transformation of the liquid to vapor and the vapor pressure in the system - A valve configured to release the vapor phase from the flow control portion - A pump configured to mix air with the vapor phase and flow the resulting mixture out of the device to the user
Method for controlled delivery of a vaporized nitrosylating agent via an ambulatory device
The method comprises: 1. Storing a nitrosylating agent in a reservoir of an ambulatory device, the reservoir comprising a storage portion (liquid phase) and a dead space portion (vapor phase) 2. Flowing the vapor phase out of the reservoir via an operably connected flow control portion 3. Controlling, by a temperature controller, the transformation of the liquid agent to vapor based on a first temperature in the reservoir 4. Controlling vapor pressure in the dead space and the flow control portion based on the first temperature (reservoir) and a second temperature (flow control portion) 5. Releasing the vapor phase from the flow control portion via a valve 6. Mixing the vapor phase with air, and pumping the mixture out of the device—where the concentration and flow rate are controlled by a pump
In summary, the patent claims cover a portable system and a corresponding method for controlled, temperature-mediated vaporization and delivery of a nitrosylating agent, with dedicated flow, mixing, and user control features.
Stated Advantages
Provides a controlled concentration delivery of a nitrosylating agent that allows for patient mobility and ambulatory use.
Enables precise regulation of agent concentration through temperature and flow control to achieve accurate dosing.
Allows the subject to avoid the need for large, non-portable gas tanks, overcoming the limitations of traditional ENO gas delivery systems.
Incorporates safety features such as closed-state valves at rest and temperature gradients to prevent unwanted release or condensation of liquid agent.
Facilitates extended operational time between refills and long battery life, supporting practical continuous use.
Documented Applications
Ambulatory delivery of a controlled concentration of nitrosylating agents, including ethyl nitrite, for patient use.
Use by patients requiring mobility while receiving controlled doses of vaporized agents, such as through a nasal cannula.
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